The highlights of this presentation by a leading FDA-CDER authority on aseptic processing isolator systems include basic design and validation approaches as well as feedback by FDA inspectors on various isolator applications during pre-approval inspections.

This section discussed the environmental qualification data and established action/alert limits for a vaccine filling system housed within an isolator. A comparison is made to conventional clean room monitoring techniques and limits.

An overview of conventional aseptic processing is presented and it addresses the key issues that corporate decision makers are faced with when implementing isolation technology, such as regulatory requirements and equipment validation focus areas.

This presentation provides an overview on the decontamination cycle and regulatory expectations for the process. Past flexible wall data and its' implications are reviewed and how new trends in validation techniques are implemented to reduce them. The benefits of rigid wall isolator construction are also discussed.

This presentation reviews the principles of microbial monitoring in isolators, current US and European regulatory requirements for monitoring, and the means to achieve and maintain a germ free environment. The current means to monitor the air and surfaces in isolators is also touched upon.